Implantation device for wireless monitoring of intracranial pressure

Abstract

The invention provides implantation equipment for wirelessly monitoring intracranial pressure. The implantation equipment comprises a shell, a flexible diaphragm, a printed circuit board, a strain gauge module and an inner cavity. The shell is composed of a flexible shell and a rigid inner core, the flexible shell is made of a biocompatible material, the rigid inner core is arranged in the flexible shell, and the flexible shell and the rigid inner core are combined to form a shell structure with a closed top and an open bottom. The flexible diaphragm is arranged at an opening in the bottom of the shell in a sealed mode and attached to the dura mater of a patient to sense intracranial pressure changes, the pressure changes are transmitted to the strain gauge module in the inner cavity, the printed circuit board is packaged at the top of the rigid inner core, and functional modules such as a signal processing module, a power module and a wireless communication module are integrated. Through the combined design of the flexible shell and the rigid inner core, the implantation device can adapt to the flexible requirement of the biological environment, the structural stability is kept, and the complexity of the implantation operation is remarkably reduced.

Description

Technical Field

[0001] The present application relates to the technical field of medical implant devices, and in particular to an implant device for wirelessly monitoring intracranial pressure. Background Art

[0002] In the field of medical implants, especially implants used to monitor intracranial pressure, the structural design of the device is crucial to its long-term stable operation after implantation. Intracranial pressure monitoring devices are mainly used to sense and transmit changes in a patient's intracranial pressure in real time so that doctors can keep track of the patient's condition. The main body of traditional intracranial pressure monitoring devices is mostly made of rigid materials to ensure the stability and mechanical strength of the device in the body. However, this design has poor adaptability to tissues during implantation, which may cause discomfort to the patient and tissue damage at the implant site.

[0003] Existing intracranial pressure monitoring devices generally use a single rigid shell structure, which can provide mechanical protection for the device in the body. However, due to its rigidity, it often causes greater compression to the patient's skull and brain tissue during implantation, affecting the adaptability between the device and the tissue. This not only increases the difficulty of device implantation, but may also cause long-term discomfort to the patient. In addition, the rigid shell has limited impact resistance and adaptability when facing the complex physiological environment of the human body, and cannot fit the dura mater well, affecting the accuracy of the monitoring data.

[0004] It can be seen that in the prior art, while the rigid shell provides mechanical strength, it lacks sufficient flexibility to adapt to the changes in tissue morphology at the implant site, causing discomfort to the patient after the device is implanted, and the device is difficult to accurately fit the dura mater for pressure transmission. Therefore, how to design an implantable device for monitoring intracranial pressure that can provide mechanical protection, is flexible, can better adapt to human tissue, and fit the dura mater has become a key issue in the design of intracranial pressure monitoring equipment. Summary of the invention

[0005] The present application provides an implantable device for wirelessly monitoring intracranial pressure, aiming to solve the problem in the prior art that patients are prone to feel discomfort after implantation of intracranial pressure monitoring devices.

[0006] The present application provides an implantable device for wirelessly monitoring intracranial pressure, comprising a housing, a flexible diaphragm, a printed circuit board, a strain gauge module, and an inner cavity;

[0007] The shell comprises a flexible shell and a rigid core, wherein the flexible shell is made of a biocompatible material, the rigid core is arranged inside the flexible shell, the rigid core and the flexible shell are connected as a whole to form a shell structure with a closed top and an open bottom, and the inner top of the rigid core is used to encapsulate the printed circuit board;

[0008] The flexible diaphragm is sealed and disposed at the bottom opening of the housing, and is used to fit the dura mater of the patient to sense changes in intracranial pressure, and is capable of transmitting the pressure changes to the strain gauge module in the inner cavity;

[0009] The printed circuit board is packaged on the inner top of the rigid core, and the printed circuit board is integrated with a signal processing unit, a power module, a wireless communication module and a posture detection module;

[0010] The strain gauge module is disposed on the top surface of the flexible diaphragm and connected to the printed circuit board through a wire, and is used to sense the deformation of the flexible diaphragm and generate a corresponding electrical signal;

[0011] The inner cavity is surrounded by the inner wall of the rigid core, and is filled with an inert gas or an electrically insulating liquid.

[0012] In another feasible embodiment, the rigid core is a cylindrical structure with a closed top and an open bottom, which is used to transmit the pressure changes of the flexible diaphragm to the strain gauge module. The inner wall of the rigid core can make the inner cavity have a truncated cone structure that is wide at the top and narrow at the bottom. The rigid core is made of titanium alloy or stainless steel.

[0013] In another feasible embodiment, the inner side wall of the rigid inner core is provided with a plurality of reinforcing ribs.

[0014] In another feasible embodiment, the flexible shell is a cylindrical structure with a closed top and an open bottom, the bottom end of the rigid core is covered by the flexible shell, the cross-section of the flexible shell is circular, the material of the flexible shell is polyimide, and the outer side of the flexible shell is provided with threads.

[0015] In another feasible embodiment, a reinforcement ring is provided at the junction of the shell and the flexible diaphragm, the reinforcement ring is fixedly connected to the inner wall of the rigid core, and the bottom surface of the reinforcement ring is in contact with and bonded to the flexible diaphragm.

[0016] In another feasible implementation manner, the inner annular surface of the reinforcement ring is a protruding arc-shaped surface.

[0017] In another feasible embodiment, a placement groove for accommodating the printed circuit board is opened at the inner top of the rigid core, and the printed circuit board is encapsulated in the placement groove of the rigid core by waterproof glue, and the signal processing unit, the power module, the wireless communication module and the posture detection module are all arranged on the printed circuit board.

[0018] In another feasible implementation, the strain gauge module includes four strain gauges arranged at different positions on the top surface of the flexible diaphragm, and the four strain gauges are interconnected to form a Wheatstone bridge structure.

[0019] In another feasible implementation, the strain gauge module is connected to the signal processing unit, the signal processing unit is connected to the wireless communication module and transmits the signal to an external device through the wireless communication module; the signal processing unit includes a signal amplifier, a filter and an analog-to-digital converter;

[0020] The signal amplifier is used to receive and amplify the electrical signal from the strain gauge module;

[0021] The filter is used to receive the electrical signal amplified by the signal amplifier and filter the noise in the electrical signal, and the input end of the filter is connected to the output end of the signal amplifier;

[0022] The analog-to-digital converter is used to receive the electrical signal processed by the filter and convert the electrical signal into a digital signal before transmitting it to the wireless communication module. The input end of the analog-to-digital converter is connected to the output end of the filter.

[0023] The posture detection module includes a gyroscope and an accelerometer, which are used to monitor the posture changes of the patient's head to generate corresponding posture data. The posture detection module is connected to the signal processing unit or the wireless communication module and can send the posture data to the signal processing unit or the wireless communication module. The wireless communication module can transmit the received posture data together with the intracranial pressure data to an external device;

[0024] The wireless communication module is configured to communicate using radio frequency communication and near field communication protocols, and can automatically switch between radio frequency communication and near field communication modes according to the distance between the implanted device and the external device to reduce the power consumption of the device within a short distance.

[0025] In another feasible embodiment, the power module includes an energy storage capacitor and a micro battery, the energy storage capacitor and the micro battery are respectively arranged on the printed circuit board, and the rigid core is provided with an induction coil capable of converting external electromagnetic energy into electrical energy through electromagnetic induction on a side opposite to the printed circuit board;

[0026] The induction coil is embedded in the outer surface of the rigid core, and is connected to the energy storage capacitor for storing the received electrical energy in the energy storage capacitor. The energy storage capacitor can receive the electrical energy from the induction coil and store it, and is used as the main power source for powering the device. The microbattery is connected in parallel with the energy storage capacitor, and when the energy storage capacitor is insufficient in power, the microbattery takes over the power supply.

[0027] Compared with the prior art, this application has the following beneficial effects:

[0028] 1. The implant device for wirelessly monitoring intracranial pressure provided by the present application, through the shell adopting a combination design of a flexible shell and a rigid core, effectively solves the problem of the traditional rigid shell causing compression to the patient's tissue during the implantation process. The flexible shell of the present application is made of biocompatible materials, which can better adapt to the physiological morphology of the patient's head. After implantation, it can better fit the dura mater and reduce the pressure on the surrounding tissues. This not only improves the patient's comfort, reduces postoperative discomfort, but also reduces the complexity of the implantation surgery. Through the organic combination of the flexible shell and the rigid core, the present application realizes that the implant device has the advantages of flexible adaptability and can ensure the mechanical protection and stability of its internal devices (such as printed circuit boards).

[0029] 2. The present application arranges the rigid core inside the flexible shell, connects the rigid core and the flexible shell as one to form a shell structure with a closed top and an open bottom, and encapsulates the printed circuit board through the inner top of the rigid core. Such a rigid core design ensures the internal stability of the implant device and the safety of the printed circuit board, while the flexible shell can better adapt to the physiological deformation of the implant site. Through this structure, the flexible shell can effectively transmit the external pressure changes to the flexible diaphragm, and the flexible diaphragm can transmit the pressure to the strain gauge module. Compared with the traditional single rigid shell design, this shell structure not only improves the sensitivity of the implant device to intracranial pressure, but also ensures the accuracy of the monitoring data, and effectively reduces the errors caused by the external environment or changes in human posture.

[0030] 3. The rigid core used in this application provides the necessary mechanical strength for the implant device, ensuring that the internal electronic devices are not damaged by external pressure or impact. At the same time, the flexible shell can play a buffering role when subjected to external forces, effectively absorbing part of the impact force, and reducing the impact of external damage on the device. In addition, the tight combination of the flexible shell and the rigid core forms a shell structure with a closed top and an open bottom. This layout not only effectively isolates the internal and external environments of the implant device, ensuring the biosafety of the implant device, but also through cooperation with the flexible diaphragm, the entire implant device has good sealing and anti-penetration performance, suitable for long-term implantation in the human body. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, a brief introduction will be given below to the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0032] Figure 1 A schematic diagram of the structure of an implant device for wirelessly monitoring intracranial pressure provided in one embodiment of the present application;

[0033] Figure 2 A schematic cross-sectional view of a housing provided in one embodiment of the present application;

[0034] Figure 3 A schematic diagram of arrangement of a strain gauge on a flexible diaphragm provided in an embodiment of the present application;

[0035] Figure 4 A schematic diagram of the structure of an implant device for wirelessly monitoring intracranial pressure provided by another embodiment of the present application;

[0036] Figure 5 A schematic diagram of the composition of a printed circuit board provided in one embodiment of the present application;

[0037] Figure 6 A schematic diagram of the composition of a signal processing unit provided in one embodiment of the present application;

[0038] Figure 7 A schematic diagram of the composition of a power module provided in one embodiment of the present application;

[0039] Figure 8 A schematic diagram of the composition of a posture detection module provided in one embodiment of the present application.

[0040] Legend:

[0041] 100, shell; 110, flexible shell; 120, rigid core; 121, reinforcing ribs; 200, flexible diaphragm; 300, printed circuit board; 310, signal processing unit; 311, signal amplifier; 312, filter; 313, analog-to-digital converter; 320, power module; 321, energy storage capacitor; 322, micro battery; 323, induction coil; 330, wireless communication module; 340, posture detection module; 341, gyroscope; 342, accelerometer; 400, strain gauge module; 410, strain gauge; 500, inner cavity; 600, reinforcing ring; 610, arc surface; 700, placement groove. DETAILED DESCRIPTION

[0042] In order to make the purpose, technical scheme and advantages of the embodiments of the present application clearer, the technical scheme in the embodiments of the present application is clearly and completely described below. Obviously, the described embodiments are part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work also fall within the scope of protection of the present application.

[0043] In order to more clearly explain the purpose, technical solutions and advantages of the embodiments of the present application, the technical solutions in the embodiments of the present application are described in detail below. It should be noted that the described embodiments are only examples of a part of the present application, not all of them. Based on the embodiments of the present application, any other implementation methods obtained by those skilled in the art without creative work belong to the protection scope of the present application.

[0044] In the description of the present application, it should be understood that the orientation or positional relationship represented by terms such as "center", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc. is based on the orientation or positional relationship shown in the drawings, and is only used to facilitate the description of the present application and simplify the description, and does not imply that the device or element must have a specific orientation, structure or mode of operation, and therefore should not be regarded as a limitation on the present application.

[0045] The terms "first", "second", etc. are used only to distinguish different technical features, and do not indicate the relative importance of the feature or a specific number of features. Therefore, a feature described as "first" or "second" may refer to one or more of the features. In this application, unless otherwise specified, "plurality" generally refers to two or more.

[0046] In the description of this application, it should be noted that, unless explicitly specified or specifically limited, the terms "installed", "connected", and "connected" should be interpreted in a broad sense, for example, they can refer to fixed connection, detachable connection, or integrated connection. For ordinary technicians in this field, the specific meanings of these terms in this application can be understood according to specific circumstances.

[0047] See also Figure 1-Figure 7 , Figure 1 A schematic diagram of the structure of an implant device for wirelessly monitoring intracranial pressure provided in an embodiment of the present application; Figure 2 A schematic cross-sectional view of a housing provided in one embodiment of the present application; Figure 3 A schematic diagram of arrangement of a strain gauge on a flexible diaphragm provided in an embodiment of the present application; Figure 4 A schematic diagram of the structure of an implant device for wirelessly monitoring intracranial pressure provided by another embodiment of the present application; Figure 5A schematic diagram of the composition of a printed circuit board provided in one embodiment of the present application; Figure 6 A schematic diagram of the composition of a signal processing unit provided in one embodiment of the present application; Figure 7 A schematic diagram of the composition of a power module provided in one embodiment of the present application; Figure 8 The following is a schematic diagram of the composition of a posture detection module provided in an embodiment of the present application. Figure 1-Figure 4 As shown, the embodiment of the present application provides an implant device for wirelessly monitoring intracranial pressure, including a housing 100, a flexible diaphragm 200, a printed circuit board 300, a strain gauge module 400 and an inner cavity 500. Specifically:

[0048] The shell 100 includes a flexible shell 110 and a rigid core 120. The flexible shell 110 is made of biocompatible material. The rigid core 120 is arranged inside the flexible shell 110. The rigid core 120 and the flexible shell 110 are connected as a whole to form a shell structure with a closed top and an open bottom. The inner top of the rigid core 120 is used to encapsulate the printed circuit board 300.

[0049] In some embodiments, the rigid core 120 and the flexible shell 110 are connected as one by bonding and fixing at the joint. When used, silicone adhesive can be used to bond the rigid core 120 and the flexible shell 110 as one. The flexibility and weather resistance of silicone adhesive make it an ideal choice for bonding the flexible shell 110 and the rigid core 120. It can adapt to the expansion and deformation of the flexible shell 110 without affecting the bonding performance. In addition, it meets the biocompatibility requirements of medical devices and is suitable for use in implanted devices inside the human body.

[0050] The flexible diaphragm 200 is sealed at the bottom opening of the housing 100, and is used to fit the patient's dura mater to sense changes in intracranial pressure, and can transmit pressure changes to the strain gauge module 400 in the inner cavity 500. Optionally, the flexible diaphragm 200 is selected from polytetrafluoroethylene, polyurethane, silicone and polyester film, has good elasticity, and can sensitively respond to changes in intracranial pressure. In some embodiments, optionally, the thickness of the flexible diaphragm 200 is 0.05mm-0.1mm. The thickness of the flexible diaphragm 200 will directly affect its flexibility, durability and sensitivity to pressure. A diaphragm that is too thick will cause a decrease in sensitivity and cannot accurately respond to subtle changes in intracranial pressure; while a diaphragm that is too thin may be damaged when used for a long time or subjected to excessive pressure. In this embodiment, combined with the monitoring requirements of human intracranial pressure, a flexible diaphragm 200 with a thickness of 0.05mm-0.1mm is used, which can provide sufficient structural strength and durability while ensuring sensitivity. Meanwhile, optionally, the maximum deformation that the flexible diaphragm 200 can withstand is at least 100 μm, so as to ensure that the implant device can still operate reliably when the intracranial pressure reaches the normal maximum value or even slightly exceeds the normal maximum value, and can provide sufficient deformation signal for the strain gauge for measurement.

[0051] In addition, in some embodiments, medical-grade polyurethane glue can be used as the bonding material between the flexible diaphragm 200 and the bottom of the shell 100, so that the flexible diaphragm 200 is firmly connected to the bottom of the shell 100. Polyurethane glue is used to bond the flexible diaphragm 200 because it has good flexibility and strength, can adapt to the deformation of the flexible diaphragm 200, and ensures its bonding strength with the shell 100 to avoid falling off or cracking when the intracranial pressure fluctuates. It also has good moisture resistance and chemical corrosion resistance, ensuring that the bonding part can maintain stability in the body for a long time without being corroded by cerebrospinal fluid. In addition, polyurethane glue can withstand certain mechanical stress, thereby better maintaining the sealing effect.

[0052] The printed circuit board 300 is packaged on the inner top of the rigid core 120, such as Figure 5As shown, the printed circuit board 300 is integrated with a signal processing unit 310, a power module 320, a wireless communication module 330 and a posture detection module 340. The printed circuit board 300 integrates the signal processing unit 310, the power module 320, the wireless communication module 330 and the posture detection module 340, and encapsulates them in the inner top of the rigid core 120. This highly integrated design effectively improves the compactness of the device structure and avoids the volume increase and connection complexity problems caused by the dispersed layout of each module in the traditional implant device. Since the key components are encapsulated inside the rigid core 120, the influence of the external environment on the electronic part of the implant device is effectively isolated, which improves the long-term stability and durability of the device. In addition, this centralized layout is also conducive to the production and manufacturing of the device and reduces the process complexity.

[0053] The strain gauge module 400 is disposed on the top surface of the flexible diaphragm 200 and connected to the printed circuit board 300 through a wire, and is used to sense the deformation of the flexible diaphragm 200 and generate a corresponding electrical signal.

[0054] The inner cavity 500 is surrounded by the inner wall of the rigid core 120, and the inner cavity 500 is filled with an inert gas or an electrically insulating liquid, so that the pressure inside and outside the inner cavity 500 is balanced to ensure the free deformation of the flexible diaphragm 200. Optionally, the electrically insulating liquid filled in the inner cavity 500 is silicone oil or fluorinated liquid. Silicone oil or fluorinated liquid is used as the electrically insulating liquid filled in the inner cavity 500, which has the advantages of low expansion coefficient and high thermal conductivity to ensure the stability of the pressure and temperature inside the inner cavity 500. The inert gas filled in the inner cavity 500 is one of argon, helium or nitrogen or a mixture of them. Filling the inner cavity 500 with electrically insulating liquid or inert gas not only optimizes the pressure conduction path, but also can effectively adjust the temperature inside the cavity 500 in the chamber, thereby reducing the impact of external temperature changes on equipment performance.

[0055] The embodiment of the present application integrates key components such as the printed circuit board 300, the strain gauge module 400 and the flexible diaphragm 200 in a closed housing by designing a housing structure combining a flexible housing 110 and a rigid core 120, thereby avoiding the risk of infection caused by external catheters or wired connections. At the same time, the flexible diaphragm 200 can fit the patient's dura mater, ensuring that changes in intracranial pressure can be accurately transmitted to the strain gauge module 400, thereby achieving high-precision monitoring.

[0056] The implant device for wirelessly monitoring intracranial pressure provided in the embodiment of the present application, through the housing 100 adopting the combined design of the flexible shell 110 and the rigid core 120, effectively solves the problem of the traditional rigid shell causing compression to the patient's tissue during the implantation process. The flexible shell 110 of the present application is made of biocompatible materials, which can better adapt to the physiological morphology of the patient's head. After implantation, it can better fit the dura mater, reducing the sense of compression on the surrounding tissue, which not only improves the patient's comfort, reduces postoperative discomfort, but also reduces the complexity of the implantation surgery. Through the organic combination of the flexible shell 110 and the rigid core 120, the present application realizes that the implant device has the advantages of flexible adaptability and can ensure the mechanical protection and stability of its internal components (such as printed circuit boards).

[0057] At the same time, the present application arranges the rigid core 120 inside the flexible shell 110, connects the rigid core 120 and the flexible shell 110 as a whole to form a shell structure with a closed top and an open bottom, and encapsulates the printed circuit board 300 through the inner top of the rigid core 120. Such a design of the rigid core 120 ensures the internal stability of the implant device and the safety of the printed circuit board 300, while the flexible shell 110 can better adapt to the physiological deformation of the implant site. Through this structure, the flexible shell 110 can effectively transmit the external pressure change to the flexible diaphragm 200, and the flexible diaphragm 200 can transmit the pressure to the strain gauge module 400. Compared with the traditional single rigid shell design, this shell structure not only improves the sensitivity of the implant device to intracranial pressure, but also ensures the accuracy of the monitoring data, and effectively reduces the error caused by the external environment or the change of human posture.

[0058] In addition, the rigid core 120 used in the present application provides the necessary mechanical strength for the implant device, ensuring that the internal electronic devices are not damaged by external pressure or impact. At the same time, the flexible shell 110 can play a buffering role when subjected to external forces, effectively absorbing part of the impact force, and reducing the impact of external damage on the device. In addition, the tight combination of the flexible shell 110 and the rigid core 120 forms a shell structure with a closed top and an open bottom. This layout not only effectively isolates the internal and external environments of the implant device, ensuring the biological safety of the implant device, but also through cooperation with the flexible diaphragm 200, the entire implant device has good sealing and anti-penetration performance, suitable for long-term implantation in the human body.

[0059] In some embodiments, the rigid core 120 is a cylindrical structure with a closed top and an open bottom, which is used to transmit the pressure changes of the flexible diaphragm 200 to the strain gauge module 400. The inner wall of the rigid core 120 can make the inner cavity 500 have a truncated cone structure that is wide at the top and narrow at the bottom. The rigid core 120 is made of titanium alloy or stainless steel.

[0060] In this embodiment, the rigid core 120 adopts a cylindrical structure with a closed upper portion and an open bottom, which not only ensures the protection of the internal electronic components, but also ensures the smooth flow of the pressure conduction path. The upper closed portion effectively protects the printed circuit board 300 and prevents the electronic components on the printed circuit board 300 from being disturbed by external pressure or mechanical stress. The open hole design at the bottom of the rigid core 120 allows the flexible diaphragm 200 to be directly connected to the inner cavity 500, ensuring that the pressure conduction is not hindered, thereby improving the sensitivity and accuracy of pressure perception.

[0061] In addition, the inner cavity 500 is designed to be a truncated cone structure that is wide at the top and narrow at the bottom, wherein the upper part accommodates the printed circuit board 300 at the inner top of the rigid core 120, and the bottom is directly connected to the flexible diaphragm 200 through a slightly smaller cross-section. This design can concentrate the pressure conduction path and ensure that the deformation of the flexible diaphragm 200 can be efficiently transmitted to the strain gauge module 400, thereby improving the sensing accuracy.

[0062] In some embodiments, the inner wall of the rigid core 120 is provided with a plurality of reinforcing ribs 121 .

[0063] In this embodiment, a plurality of reinforcing ribs 121 are arranged on the inner wall of the rigid core 120, and the plurality of reinforcing ribs 121 are evenly arranged on the inner wall of the rigid core 120, which is a design to further enhance the strength of the rigid core 120. The arrangement of the reinforcing ribs 121 effectively improves the mechanical strength of the rigid core and prevents the implanted device from being deformed or damaged due to the long-term effect of external pressure. This design can show better stability in the intracranial environment.

[0064] In some embodiments, the flexible housing 110 is a cylindrical structure with a closed top and an open bottom. Figure 1 As shown, the bottom of the rigid core 120 is covered by a flexible shell 110, the cross section of the flexible shell 110 is annular, the material of the flexible shell 110 is polyimide (PI), and the outer side of the flexible shell 110 is provided with threads. Figure 4 As shown, the bottom end of the rigid core 120 is not covered by the flexible shell 110 , that is, there is no flexible shell 110 between the bottom end of the rigid core 120 and the flexible diaphragm 200 .

[0065] The use of the flexible shell 110 enables the implant device of the present application embodiment to quickly and well adapt to the shape of the cranial hole and slight pressure changes when in contact with the skull, reducing the pressure and wear on the surrounding tissues. This design is particularly suitable for the high sensitivity of head tissues, can reduce postoperative discomfort and inflammatory reactions, and avoid the implant device from causing long-term damage to the cranial hole and surrounding tissues, thereby improving biocompatibility.

[0066] In this embodiment, the flexible shell 110 used has good flexibility and biocompatibility, and can be implanted close to the patient's skull surface. The flexible shell 110 is made of polyimide (PI), which has excellent flexibility, high temperature resistance and mechanical strength, and has very good mechanical stability. It will not be easily deformed even if bent. It also has excellent biocompatibility and is a better choice for implantable medical devices.

[0067] In addition, the cylindrical structure of the flexible shell 110 with a closed top and an open bottom enables the flexible shell 110 to provide necessary structural protection when the device is implanted, while enabling the strain gauge module 400 and the flexible diaphragm 200 at the bottom opening to directly sense changes in intracranial pressure, effectively maintaining the sensitivity of sensing.

[0068] In this embodiment, the bottom of the rigid core 120 is covered by the flexible shell 110, which provides dual structural support for the bottom of the housing 100. The flexible shell 110 can absorb appropriate impact or pressure on the outside, while the rigid core 120 can maintain the structural integrity of the internal components. This covering design enhances the overall mechanical stability of the device and reduces the risk of loosening or displacement of the device, especially during the daily activities of the patient after implantation.

[0069] In this embodiment, threads are provided on the outer side of the flexible housing 110, which provides a good fixing function for the implant device of the embodiment of the present application. The setting of the threads allows the implant device to enter the cranial hole by rotation during installation, forming a more stable mechanical connection, which not only improves the convenience of surgical installation, but also effectively prevents the implant device from falling off or shifting. The thread design ensures that no additional clamps or fixing devices are required during the installation of the device, and the installation is simple and quick, and it is also convenient for the adjustment or replacement of the device at a later stage. This design not only simplifies the surgical process, but also reduces the operation time and the probability of postoperative complications.

[0070] The flexible housing 110 adopts a circular cross-section design, which can be quickly and accurately aligned with the cranial hole when used, avoiding complicated surgical operations. In addition, the circular design reduces stress concentration at the contact part with the skull, further improving the stability of the device.

[0071] The installation and fixation process of the implant device for wireless monitoring of intracranial pressure provided in the embodiment of the present application is as follows:

[0072] In surgery, after drilling a hole in the skull, the doctor will expose the location of the skull hole for placement of the implant device of the embodiment of the present application. Then the implant device is placed. When placing the implant device, the implant device is first gently placed in the skull hole, and the threaded structure of the flexible shell 110 contacts the inner wall of the skull hole. By rotating the implant device, the threaded structure gradually screws the implant device into the skull hole, ensuring that the implant device is tightly fixed to the skull wall, reducing the risk of the implant device falling off or displacing. After being stably fixed, the flexible shell 110 provides the necessary absorption or relief of externally applied pressure or impact, while the rigid core 120 maintains the stability of the internal components of the implant device, and the flexible diaphragm 200 at the bottom of the implant device fits tightly with the intracranial pressure sensing area, thereby achieving effective intracranial pressure monitoring.

[0073] An important aspect of the implant device for wirelessly monitoring intracranial pressure in the embodiment of the present application needs to be highlighted, that is, the combination design of the flexible shell 110 and the rigid core 120 adopted in the embodiment of the present application reduces the complexity of the implantation surgery. Specifically:

[0074] First, the flexible shell 110 of the embodiment of the present application is made of a biocompatible material, which has a certain plasticity and compliance. This property enables the implant device to better adapt to the patient's physiological structure during the implantation process, especially under the different shapes or anatomical differences of the patient's skull and meninges. The flexible shell 110 can be slightly bent or deformed, thereby reducing the requirements for precise positioning of the device during the operation. Traditional implant devices using rigid shells require very precise cutting and implantation path design during implantation, otherwise it may cause the implant device to be incompatible with the tissue, thereby increasing the operation time and difficulty. The flexible shell 110 can better conform to the surgical area, reduce the demanding requirements for cutting accuracy, and reduce the foreign body sensation after the device is implanted.

[0075] Secondly, the rigid core 120 is responsible for providing the basic structural strength and support for the implant device. Since the rigid core 120 carries the important electronic components of the implant device and can maintain the overall shape unchanged, during the implantation process, the surgeon only needs to install the device in a normal predetermined manner, without having to worry too much about deformation or damage to the implant device due to pressure during the implantation process. Compared with a completely flexible design, the presence of the rigid core 120 allows the implant device to maintain a fixed shape, ensuring that the implant device after implantation will not be deformed due to external pressure or squeezing of tissues in the body. This combination of rigidity and flexibility makes the implantation process more intuitive. The surgeon only needs to deal with the adaptability of the flexible shell 110 without having to worry too much about the stability of the device, thereby simplifying the operation steps.

[0076] Furthermore, the flexible diaphragm 200 is sealed at the bottom opening of the housing 100, and because the bottom end of the rigid core 120 is covered by the flexible shell 110, the part of the implant device that contacts the patient's meninges has high softness and compliance. This design not only reduces the foreign body sensation in the patient's body, but also reduces the risk of postoperative infection and complications. The sealing design of the flexible diaphragm 200 can maintain good contact between the implant device and the brain tissue while reducing the complexity of the operation, ensuring accurate sensing of intracranial pressure. This design not only reduces the excessive demands on the shape of the implant device, but also can flexibly respond to the patient's physiological changes during the operation, and the surgeon can more easily fix the implant device in place.

[0077] In some embodiments, a reinforcing ring 600 is provided at the joint between the housing 100 and the flexible membrane 200. The reinforcing ring 600 is fixedly connected to the inner wall of the rigid core 120, and the bottom surface of the reinforcing ring 600 is in contact with and bonded to the flexible membrane 200. Figure 4 As shown, when the bottom circle of the rigid core 120 is not covered by the flexible shell 110, the reinforcing ring 600 and the inner wall of the rigid core 120 are directly fixedly connected together by bonding; Figure 1 As shown, when the bottom end of the rigid core 120 is covered by the flexible shell 110, the reinforcing ring 600 and the inner wall of the rigid core 120 are fixedly connected together by bonding, and the reinforcing ring 600 is also bonded to the inner wall of the flexible shell 110 to further maintain stability.

[0078] In this embodiment, a reinforcing ring 600 is provided at the joint between the housing 100 and the flexible diaphragm 200 to enhance the connection strength between the two, thereby ensuring that the flexible diaphragm 200 will not loosen or shift under high pressure. The introduction of the reinforcing ring 600 can effectively disperse the stress caused by external pressure changes, avoid local stress concentration, and cause equipment damage, thereby improving the overall reliability of the equipment, and also optimizing the transmission efficiency of pressure sensing. Compared with the design of direct connection without a reinforcing ring 600 in the prior art, the introduction of the reinforcing ring 600 significantly improves the mechanical strength and connection stability of the device, especially in the complex intracranial environment, the design shows outstanding characteristics.

[0079] In some embodiments, the inner annular surface of the reinforcement ring 600 is a protruding arc-shaped surface 610 .

[0080] The inner ring surface of the reinforcing ring 600 is designed with an arc surface. Such an arc surface 610 can effectively disperse stress, avoid the problem of stress concentration at the contact point, and make the implant device more stable in the complex intracranial environment. This embodiment optimizes the stress distribution at the junction of the rigid core 120 and the flexible diaphragm 200 of the device through the arc surface design, so that the device can better cope with pressure changes and significantly reduce the risk of mechanical fatigue or damage caused by stress concentration.

[0081] In addition, it should be noted that the arc surface design of the reinforcing ring 600 seems simple, but in fact it also helps to protect the flexible diaphragm 200 from damage during long-term use to a certain extent. When the flexible diaphragm 200 is deformed under pressure, its edge area is usually the part where the stress is most concentrated, and this stress concentration will accelerate the fatigue and wear of the material. The arc surface 610 can smoothly disperse the stress and avoid the concentrated stress from causing excessive load on the edge of the flexible diaphragm, thereby effectively extending the service life of the flexible diaphragm 200. Moreover, since the arc surface 610 of the reinforcing ring 600 is a smooth curved surface, during the repeated deformation of the flexible diaphragm 200, the contact surface between the diaphragm and the reinforcing ring 600 is softer, thereby reducing the risk of wear. In addition, the arcuate surface 610 provides a larger contact surface. When the flexible diaphragm 200 is deformed, the pressure can be evenly distributed on the arcuate surface 610 of the reinforcement ring 600, so that the arcuate surface 610 can increase the deformation bearing capacity of the flexible diaphragm 200 while maintaining structural tightness, thereby avoiding material damage caused by excessive local pressure.

[0082] In some embodiments, a placement groove 700 for accommodating the printed circuit board 300 is provided at the inner top of the rigid core 120. The printed circuit board 300 is encapsulated in the placement groove 700 of the rigid core 120 by waterproof glue to form a sealed protection to prevent liquid from penetrating and protect electronic components. The signal processing unit 310, the power module 320, the wireless communication module 330 and the posture detection module 340 are all arranged on the printed circuit board 300.

[0083] In this embodiment, a placement groove 700 for accommodating the printed circuit board 300 is set at the inner top of the rigid core 120, and the printed circuit board 300 is packaged with waterproof glue. Such a waterproof packaging design significantly enhances the ability of the printed circuit board 300 to prevent liquid intrusion. Especially in an implantation environment, the printed circuit board is not easily damaged by liquid penetration, thereby extending the service life of the device.

[0084] Moreover, such a layout is compact and reasonable. By encapsulating the printed circuit board 300 at the inner top of the rigid core 120 and placing the groove 700, a safer and more stable structural design is provided, which not only saves space but also reduces possible displacement risks.

[0085] Traditional designs usually rely on a simple sealed housing, while this embodiment combines waterproof glue and a dedicated placement groove 700, and is further protected by a shell 100 on the outside. This multi-level packaging design innovation improves the protection of the printed circuit board 300, thereby ensuring that the device can maintain functional integrity in harsh biological environments.

[0086] Optionally, the waterproof glue used for encapsulating the printed circuit board 300 in the placement groove 700 is silicone glue. Silicone glue (Silicone Sealant) is a better choice. Silicone glue is a material commonly used in the packaging of medical devices. It will not cause rejection or allergic reactions in the body and is very suitable for the packaging of implanted devices. In addition, silicone glue has excellent waterproof performance, which can effectively prevent liquids (such as cerebrospinal fluid) from penetrating into the interior of the device, thereby protecting the printed circuit board 300 and the electrical components thereon from moisture damage, ensuring the long-term stability of the device, and its excellent sealing can also prevent the intrusion of air and moisture, thereby improving the durability of the device in a humid environment. In addition, silicone glue has a wide range of temperature resistance (usually from -60°C to +200°C), and can maintain stability within the normal operating temperature range of the device, and will not lose its sealing or degrade due to temperature changes. More importantly, silicone glue has excellent flexibility, can absorb mechanical vibration and shock, and prevent the device from being damaged in external environments such as changes in intracranial pressure and patient movement.

[0087] From the above, it can be seen that the use of silicone glue as the waterproof glue for encapsulating the printed circuit board 300 can effectively meet the waterproof, temperature-resistant, shock-resistant and biocompatibility requirements of the device. Its good sealing performance can ensure the long-term stable operation of the device in the body, effectively protect the internal electronic components, and improve the reliability and durability of the overall device.

[0088] In some embodiments, the strain gauge module 400 includes four strain gauges 410 arranged at different positions on the top surface of the flexible diaphragm 200. The four strain gauges 410 are interconnected to form a Wheatstone bridge structure for detecting the deformation of the flexible diaphragm 200 and generating electrical signals to improve the sensitivity and accuracy of intracranial pressure detection.

[0089] The strain gauge module 400 of this embodiment uses four strain gauges 410 connected to each other to form a Wheatstone bridge structure for sensing the deformation of the flexible diaphragm 200. Through the Wheatstone bridge structure, the tiny electrical signal generated by the strain gauge module 400 can be amplified, significantly improving the accuracy and sensitivity of pressure sensing. This structure is very sensitive to tiny changes in intracranial pressure, ensuring the accuracy of monitoring data.

[0090] At the same time, the Wheatstone bridge structure can effectively balance the noise in the circuit, reduce the impact of external interference on the signal, and ensure the stability of the signal quality. Although the Wheatstone bridge is a common signal processing structure, it is not common to use it in combination with the flexible diaphragm 200 in an implant device. Through this combination, the embodiment of the present application significantly reduces the problem of the traditional implant device signal being susceptible to interference and low precision.

[0091] In a specific application, four strain gauges 410 are set on the flexible diaphragm 200 by bonding. Specifically, epoxy resin glue can be used to bond the strain gauge 410 to the flexible diaphragm 200. Epoxy resin glue not only has excellent bonding properties, but also can ensure that the strain gauge 410 is firmly bonded to the flexible diaphragm 200, so that the strain gauge 410 will not be loosened or offset due to slight deformation of the diaphragm. Moreover, after curing, epoxy resin glue can effectively withstand high stress and has good thermal stability, which can ensure that the strain gauge 410 remains stable during the pressure sensing process and can be used reliably.

[0092] The strain measurement range of the strain gauge 410 needs to match the maximum deformation of the flexible diaphragm 200 to ensure that the strain gauge 410 can accurately measure the pressure change when the flexible diaphragm 200 is deformed. The thickness and maximum deformation of the flexible diaphragm 200 determine the deformation amplitude of the diaphragm when the intracranial pressure changes, and the strain measurement range of the strain gauge 410 is limited according to the actual deformation of the diaphragm to ensure that the strain gauge 410 is effectively measured within the normal working range. In some of the embodiments mentioned above, the thickness of the flexible diaphragm 200 is limited to 0.05mm-0.1mm, and the maximum deformation that the flexible diaphragm 200 can withstand is limited to at least 100μm in combination with the use requirements of intracranial pressure monitoring. Optionally, in this embodiment, the strain measurement range of the strain gauge 410 used in the strain gauge module 400 is: 100με-2000με (micro strain). In order to ensure that the measurement range of the strain gauge is wide enough, it is recommended that the strain measurement range of the strain gauge 410 is 100με to 2500με to meet the application requirements of the flexible diaphragm 200 within the deformation range of 10μm to 100μm. Selecting this strain range can more appropriately ensure that the strain gauge 410 can accurately detect the deformation of the flexible diaphragm 200, and at the same time, it will not cause signal noise or measurement errors due to the strain gauge 410 being too sensitive or not sensitive enough.

[0093] By limiting the strain measurement range of the strain gauge 410 and the thickness of the flexible diaphragm 200, it can be more appropriately ensured that the combination of the flexible diaphragm 200 and the strain gauge 410 can accurately respond to changes in intracranial pressure, achieve high-sensitivity and high-precision pressure measurement, and at the same time ensure the long-term service life and reliability of the implanted device. This matching design provides a guarantee for the stability and accuracy of the implanted device.

[0094] In some embodiments, four strain gauges 410 are optionally arranged symmetrically on the top surface of the flexible diaphragm 200 in pairs to form a Wheatstone bridge structure. This layout can eliminate noise and signal drift to the greatest extent and improve the accuracy and sensitivity of the signal. Specifically, the following methods can be used:

[0095] Four strain gauges 410 are arranged in a diamond shape on the top surface of the flexible diaphragm 200, wherein two strain gauges (respectively labeled A and B) are placed symmetrically along the radial direction of the diaphragm centerline, and the other two strain gauges (C and D) are placed perpendicular to the directions of A and B and are also symmetrically arranged near the edge of the diaphragm. This arrangement allows the strain gauges 410 to detect the tension and compression in different stress directions caused by pressure changes to the maximum extent.

[0096] The four strain gauges 410 are arranged in a diamond shape to take into account the middle and edge areas of the diaphragm as much as possible, ensuring that the strain changes under the external pressure can be sensitively captured. When in use, the strain gauges near the center sense the tensile force, while the strain gauges at the edge sense the compressive force, so that the overall deformation of the diaphragm can be fully monitored.

[0097] In some embodiments, Figure 5 As shown, the strain gauge module 400 is connected to the signal processing unit 310, and the signal processing unit 310 is connected to the wireless communication module 330 and transmits the signal to the external device through the wireless communication module 330; Figure 6 As shown, the signal processing unit 310 includes a signal amplifier 311 , a filter 312 , and an analog-to-digital converter 313 , and is used to process the electrical signal received from the strain gauge module 400 .

[0098] The signal amplifier 311 is used to receive and amplify the electrical signal from the strain gauge module 400 .

[0099] The filter 312 is used to receive the electrical signal amplified by the signal amplifier 311 and filter the noise in the electrical signal. The input end of the filter 312 is connected to the output end of the signal amplifier 311 .

[0100] The analog-to-digital converter 313 is used to receive the electrical signal processed by the filter 312 and convert the electrical signal into a digital signal and then transmit it to the wireless communication module 330 . The input end of the analog-to-digital converter 313 is connected to the output end of the filter 312 .

[0101] like Figure 8As shown, the posture detection module 340 includes a gyroscope 341 and an accelerometer 342, which are used to monitor the posture changes of the patient's head to generate corresponding posture data. The posture detection module 340 is connected to the signal processing unit 310 or the wireless communication module 330, and can send the posture data to the signal processing unit 310 or the wireless communication module 330. Figure 6 Only the connection mode of the posture detection module 340 and the signal processing unit 310 is shown in the figure, and the connection mode of the posture detection module 340 and the wireless communication module 330 is omitted in the figure. Here, only a specific method is given as an example. The wireless communication module 330 can transmit the received posture data together with the intracranial pressure data to an external device, thereby helping doctors to more accurately analyze the changing trend of intracranial pressure. In addition, the posture data can also be used to correct the measurement error caused by the patient's posture change, ensuring the measurement accuracy of the device in different body positions, so as to improve the clinical application value of the device.

[0102] The wireless communication module 330 is configured to communicate using radio frequency communication and near field communication protocols, and can automatically switch between radio frequency communication and near field communication modes according to the distance between the implanted device and the external device to reduce the power consumption of the device within a short distance.

[0103] Signal processing and wireless transmission are the core functions of intracranial pressure monitoring equipment. Traditional implanted devices for intracranial pressure monitoring face problems of poor signal quality and high power consumption. In the embodiment of the present application, the signal processing unit 310 includes a signal amplifier 311, a filter 312 and an analog-to-digital converter 313. The signal amplifier 311 can amplify weak electrical signals, the filter 312 can remove noise from the signal, and the analog-to-digital converter 313 can digitize the signal, thereby ensuring that the signal quality before transmission is effectively guaranteed. This multi-level signal processing greatly improves the reliability of the intracranial pressure monitoring equipment.

[0104] Moreover, by automatically switching between radio frequency communication and near field communication modes through the wireless communication module 330, the implanted device can select the appropriate communication mode according to the distance from the external device, thereby reducing power consumption and extending battery life. At the same time, unlike traditional devices that can only rely on a single communication mode, this embodiment can switch the communication mode to effectively reduce power consumption while ensuring communication quality, which is particularly suitable for long-term use of implanted devices. Such a design shows unique innovation in the field of implantable medical devices.

[0105] In practical applications, the intracranial pressure measurement results can be corrected by acquiring the posture data of the posture detection module 340 to improve the accuracy of the measurement. When the posture detection module 340 is connected to the signal processing unit 310, a correction module can be added to the signal processing unit 310, and then the intracranial pressure data is corrected by the signal processing unit 310 according to the posture data; when the posture detection module 340 is connected to the wireless communication module 330, the posture data and the intracranial pressure data are transmitted to the external device through the wireless communication module 330, and then the intracranial pressure data can be corrected by the external device according to the posture data obtained synchronously. In specific applications, the application can be flexibly configured according to actual needs.

[0106] In some embodiments, Figure 7 As shown, the power module 320 includes a storage capacitor 321 and a micro battery 322, which are respectively arranged on the printed circuit board 300, and the rigid core 120 is provided with an induction coil 323 on the side opposite to the printed circuit board 300, which can convert external electromagnetic energy into electrical energy through electromagnetic induction.

[0107] The induction coil 323 is embedded in the outer surface of the rigid core 120. The induction coil 323 is connected to the energy storage capacitor 321 and is used to store the received electric energy in the energy storage capacitor 321. The energy storage capacitor 321 can receive the electric energy from the induction coil 323 and store it, and is used as the main power source for powering the device. The micro battery 322 is connected in parallel with the energy storage capacitor 321. When the energy storage capacitor 321 is insufficient in power, the micro battery 322 takes over the power supply.

[0108] In the power module 320 of this embodiment, the energy storage capacitor 321 and the micro battery 322 are designed in parallel, and the power module 320 and the induction coil 323 are designed to be combined. The induction coil 323 is used to charge the energy storage capacitor 321 through electromagnetic induction, and the implanted device is powered by the energy storage capacitor 321. When the energy storage capacitor 321 is insufficient in power, the micro battery 322 can take over the power supply as a backup power supply.

[0109] This design can provide dual power supply guarantee for the implant device used for wireless monitoring of intracranial pressure in the embodiment of the present application. The energy storage capacitor 321 is used to provide the main power supply for the implant device, and when the energy storage capacitor 321 is low on power, the micro battery 322 automatically takes over the power supply. This method ensures the continuity of power supply to the implant device and avoids interruption of the implant device due to insufficient power. As a backup power supply, the micro battery 322 can ensure that the implant device can still work normally when it cannot obtain sufficient energy through the induction coil 323.

[0110] In addition, it should be noted that the location of the induction coil 323 is very important in the overall design of the implant device. It needs to ensure good electromagnetic induction performance and ensure that it will not interfere with other parts of the implant device (such as electronic components or housing). In this embodiment, the induction coil 323 is embedded in the outer surface of the rigid core 120. Since the rigid core 120 is relatively strong, the induction coil 323 is embedded in the outer surface of the rigid core 120, and the surrounding of the induction coil 323 can be protected by the rigid core 120 to reduce external physical damage. Moreover, this position can make the induction coil 323 between the flexible shell 110 and the rigid core 120, so that the induction coil 323 can be arranged more appropriately in a limited space, ensuring that the coil is in the core position of the implant device, so as not to hinder the induction signal, and can effectively receive external energy, and this position is convenient for connecting with the energy storage capacitor 321, so as to store electrical energy through the energy storage capacitor 321 in time.

[0111] The power supply of traditional implantable devices relies on a single battery, and the application of wireless charging technology is often limited by the charging efficiency and the structural complexity of the device. The embodiment of the present application realizes wireless charging through the induction coil 323, and the induction coil 323 can receive energy from an external device through electromagnetic induction, thereby charging the energy storage capacitor 321. During specific use, the energy storage capacitor 321 can be charged regularly through the induction coil 323 to power the implantable device. In this way, the implantable device does not need to replace the battery frequently, which greatly facilitates the daily use and maintenance of the implantable device, and prolongs the use time of the implantable device and improves the power supply reliability.

[0112] It can be seen that the combined design of inductive charging and dual power supply adopted in this embodiment can solve the power supply bottleneck problem of traditional implanted devices in long-term use, especially in the field of implanted devices. This design of wireless power supply and dual power management provides guarantee for the long-term operation of implanted devices, allowing implanted devices to operate for a long time without frequent battery replacement, thereby improving the practicality of implanted devices. At the same time, the energy transmission between the induction coil 323 and the external device also provides flexibility for the power supply of the device.

[0113] In summary, the implant device for wirelessly monitoring intracranial pressure provided by the embodiment of the present application can more accurately sense the changes in the patient's intracranial pressure through the coordinated work of various components, and transmit the data to an external device in real time, providing reliable data support for medical diagnosis. The innovation of this implant device for wirelessly monitoring intracranial pressure lies in its reasonable structural layout, dual power supply guarantee, and communication mode switching. It also combines a number of advanced technologies and demonstrates high practical value.

[0114] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present application, rather than to limit it. Although the present application has been described in detail with reference to the aforementioned embodiments, ordinary technicians in the field should understand that they can still modify the technical solutions recorded in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present application.

Claims

1. An implantable device for wirelessly monitoring intracranial pressure, characterized in that: It comprises a housing (100), a flexible diaphragm (200), a printed circuit board (300), a strain gauge module (400) and an inner cavity (500); The housing (100) comprises a flexible housing (110) and a rigid core (120), wherein the flexible housing (110) is made of a biocompatible material, and the rigid core (120) is arranged inside the flexible housing (110), and the rigid core (120) and the flexible housing (110) are connected as a whole to form a housing structure with a closed top and an open bottom, and the inner top of the rigid core (120) is used to encapsulate the printed circuit board (300); The flexible diaphragm (200) is sealed and disposed at the bottom opening of the housing (100), and is used to fit the dura mater of the patient to sense changes in intracranial pressure, and is capable of transmitting the pressure changes to the strain gauge module (400) in the inner cavity (500); The printed circuit board (300) is packaged on the inner top of the rigid core (120), and a signal processing unit (310), a power module (320), a wireless communication module (330) and a posture detection module (340) are integrated on the printed circuit board (300); The strain gauge module (400) is arranged on the top surface of the flexible diaphragm (200), connected to the printed circuit board (300) via a wire, and is used to sense the deformation of the flexible diaphragm (200) and generate a corresponding electrical signal; The inner cavity (500) is surrounded by the inner wall of the rigid core (120), and the inner cavity (500) is filled with an inert gas or an electrically insulating liquid.

2. The implant device for wirelessly monitoring intracranial pressure according to claim 1, characterized in that: The rigid core (120) is a cylindrical structure with a closed top and an open bottom, and is used to transmit the pressure change of the flexible diaphragm (200) to the strain gauge module (400). The inner wall of the rigid core (120) can make the inner cavity (500) have a truncated cone structure that is wide at the top and narrow at the bottom. The rigid core (120) is made of titanium alloy or stainless steel.

3. The implant device for wirelessly monitoring intracranial pressure according to claim 1 or 2, characterized in that: The inner side wall of the rigid inner core (120) is provided with a plurality of reinforcing ribs (121).

4. The implant device for wirelessly monitoring intracranial pressure according to claim 1, characterized in that: The flexible shell (110) is a cylindrical structure with a closed top and an open bottom. The bottom end of the rigid core (120) is covered by the flexible shell (110). The cross-section of the flexible shell (110) is annular. The material of the flexible shell (110) is polyimide. The outer side of the flexible shell (110) is provided with a thread.

5. The implant device for wirelessly monitoring intracranial pressure according to claim 3, characterized in that: A reinforcement ring (600) is provided at the joint between the shell (100) and the flexible diaphragm (200), the reinforcement ring (600) is fixedly connected to the inner wall of the rigid core (120), and the bottom surface of the reinforcement ring (600) is in contact with and bonded to the flexible diaphragm (200).

6. The implant device for wirelessly monitoring intracranial pressure according to claim 5, characterized in that: The inner annular surface of the reinforcement ring (600) is a protruding arc-shaped surface.

7. The implant device for wirelessly monitoring intracranial pressure according to any one of claims 4 to 6, characterized in that: The inner top of the rigid core (120) is provided with a placement groove (700) for accommodating the printed circuit board (300); the printed circuit board (300) is encapsulated in the placement groove (700) of the rigid core (120) by waterproof glue; and the signal processing unit (310), the power module (320), the wireless communication module (330) and the posture detection module (340) are all arranged on the printed circuit board (300).

8. The implant device for wirelessly monitoring intracranial pressure according to claim 1, characterized in that: The strain gauge module (400) comprises four strain gauges (410) arranged at different positions on the top surface of the flexible diaphragm (200), and the four strain gauges (410) are interconnected to form a Wheatstone bridge structure.

9. The implant device for wirelessly monitoring intracranial pressure according to claim 1 or 8, characterized in that: The strain gauge module (400) is connected to the signal processing unit (310), and the signal processing unit (310) is connected to the wireless communication module (330) and transmits the signal to an external device through the wireless communication module (330); the signal processing unit (310) comprises a signal amplifier (311), a filter (312) and an analog-to-digital converter (313); The signal amplifier (311) is used to receive and amplify the electrical signal from the strain gauge module (400); The filter (312) is used to receive the electrical signal amplified by the signal amplifier (311) and filter noise in the electrical signal, and the input end of the filter (312) is connected to the output end of the signal amplifier (311); The analog-to-digital converter (313) is used to receive the electrical signal processed by the filter (312), convert the electrical signal into a digital signal, and transmit the digital signal to the wireless communication module (330), wherein the input end of the analog-to-digital converter (313) is connected to the output end of the filter (312); The posture detection module (340) comprises a gyroscope (341) and an accelerometer (342), and is used to monitor changes in the posture of the patient's head to generate corresponding posture data. The posture detection module (340) is connected to the signal processing unit (310) or the wireless communication module (330), and is capable of sending the posture data to the signal processing unit (310) or the wireless communication module (330). The wireless communication module (330) is capable of transmitting the received posture data together with the intracranial pressure data to an external device. The wireless communication module (330) is configured to communicate using radio frequency communication and near field communication protocols, and can automatically switch between radio frequency communication and near field communication modes according to the distance between the implanted device and the external device, so as to reduce the power consumption of the device within a short distance.

10. The implant device for wirelessly monitoring intracranial pressure according to claim 9, characterized in that: The power module (320) comprises an energy storage capacitor (321) and a micro battery (322), wherein the energy storage capacitor (321) and the micro battery (322) are respectively arranged on the printed circuit board (300), and the rigid core (120) is provided with an induction coil (323) capable of converting external electromagnetic energy into electrical energy through electromagnetic induction on a side opposite to the printed circuit board (300); The induction coil (323) is embedded in the outer surface of the rigid core (120). The induction coil (323) is connected to the energy storage capacitor (321) and is used to store the received electric energy in the energy storage capacitor (321). The energy storage capacitor (321) can receive the electric energy from the induction coil (323) and store it, and is used as the main power source when powering the device. The micro battery (322) is connected in parallel with the energy storage capacitor (321). When the power of the energy storage capacitor (321) is insufficient, the micro battery (322) takes over the power supply.

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